17 replies to this topic

[D-D]

Anyone got some suggestions on the best way of validating cleaning procedures for mixing vessels? (If it helps: used for 'low risk' products i.e. manufacture of additives used in tiny amounts and not consumer-ready foods).

We do not handle high profile allergens like nuts so in the absence of dedicated equipment I was considering using the validated standard cleaning procedures as suitable for allergens too. We could do ATP swabbing for that to show no proteins present but I am not sure that would be applicable for general cleaning validation e.g. there may be no proteins present but that would not address residues of cleaning chemicals...

Maybe analyse somehow for Micro-90 and LQ39 cleaning agent residues...?

Thanks.

[Charles.C]

Dear D-D,

Well, I don't know what yr products are but separating the issues of allergens and cleaning, the usual simplest answer to validating cleaning is by swab testing to demonstrate the result is adequate. ATP is quicker obviously but perhaps more contentious over interpretation from an auditorial aspect. Personally I hv never had the funds to go the ATP route.

I don't know if such data is suitable for allergen aspects also since never had the problem. Seems a not unreasonable approach to me. Anybody ??

Rgds / Charles.C

[Tony-C]

Maybe analyse somehow for Micro-90 and LQ39 cleaning agent residues...?

Thanks.

You can use pH and/or taste to check for cleaning agent residues.

Regards,

Tony

[Madam A. D-tor]

Hello D-D,

Which allergens do you have on site?

Also for not high-risk allergens detection is possible.
In an ideal allergen validation plan: you produce allergen containing products, clean as usual and start to produce the non-allergen containing product. The first X products are samples and analysed for allergen-spores.

As an auditor I do not accept validation based on colour for allergen validation. You know, when some companies produce a white product after a red product. They say that the cleaning is validated if there is no red colour visible in the white product. I would not accept that, because colour particles the size of allergen spores would not be visually observed.

Validation of cleaning/desinfection on microbiological base: ATP is a good instrument. But swabs and rodac plates are also applicable.

I hope this information was of any help.

[D-D]

Thanks all for the input.
Our allergens include mustard, celery, gluten, dairy products (and soya I think too).
Not sure what you mean Madam A about testing for allergen 'spores' - that would imply mould etc, non?

[Madam A. D-tor]

Hello D-D,

I am sorry, I must have been using a wrong translation.
At the moment I do not know the English word for it, but I found somewhere a discription: "the small amounts of residual allergens that are not part of the formulation of a manufactured food product but may be present due to the production process".
Could "traces" be the word I ment?

[bibi]

sorry what is LQ39?
chemicals residues good one, what about titration of the rinsing water?
bibi

[Biss]

Hi,

After cleaning we are testing the following parameters in the final rinsed water

a) Traces of previous proudct by sensory evaluation
b) Traces of cleaning agent


you can use the following approach for validation


1. Pre-validation Tasks

• Hazard(s): Generic microbial contaminants
• Food Safety Outcome: Effective sanitation of food-contact surfaces as demonstrated by compliance with microbiological criteria.
• Control Measure(s): Cleaning and disinfection protocols (SSOPs) within a facility

2. Approach: Collection of scientific data.

3. Parameters and Decision Criteria: SSOPs will be considered to be validated if, after implementation of cleaning and disinfection protocols, food contact surfaces meet microbiological criteria established for aerobic plate counts or other indicator microorganisms as appropriate.

4. Assemble the relevant validation information

• SSOPs will be implemented as intended for 3-4 weeks of operation.
• Microbiological testing of food contact surfaces will be conducted after cleaning and disinfection protocols have been used at the end of each day’s production.

5. Analyze the results

• Compare results obtained at the end of each day’s production to the established microbiological criteria.
• Conduct appropriate statistical analyses to determine the variability in efficacy of the cleaning and disinfection procedures.

6. Document and review the validation

• Data from implementation of SSOPs should be documented.
• All data from food contact surface testing should be documented.

7. Conclusion

If review and analysis of the validation results indicate that the SSOPs are capable of consistently delivering results that comply with the established microbiological criteria during 3-4 weeks of the validation period, then the cleaning and disinfection protocols can be considered validated.

This same protocol with a reduced rate of testing can be used as an ongoing verification activity that the SSOPs are being implemented properly.

[D-D]

Thanks Biss - that's great.

Madam - I think 'traces' was definitely the word.

bibi - LQ39 is a cleaner from Deosan used in dairy (we are not dairy but it is useful).

[Charles.C]

Dear D-D,

Just to slightly amplify Biss's nice post, based on Codex I think -

 Codex_validation_with_cleaning_example3___cxg_069e.pdf   170.26KB   520 downloads

Rgds / Charles.C

[D-D]

Just coming back to this...
I have seen "Allergen wash" products for laundry; does anybody know if such things exist for processing equipment in the food industry? Alternatively, are there any studies to say if you flush through with say, caustic at pH X this will denature protein-related allergens?
I am sure I am going beyond requirements given our actual level of risk (we have never had an issue) but I just want to make sure we have a water tight case by saying we have washed with a specifically designed product (if such a things exists...).

[GMO]

I believe you can buy swabs to detect traces of the proteins in the allergenic material? I wouldn't personally use these all the time because they're not cheap from memory but it might help validate the cleaning process?

http://www.3mselect....swabs-pack.aspx

As for cleaning efficacy, I've just done micro swabs in the past and the last stage (disinfection) is a chemical which is food safe so it wouldn't matter if traces are present. For tanks, as mentioned above as caustic is often used, pH or titration might be the best way.

[nateb]

I'll give one more perspective to this discussion. ATP based swabs are VERY useful for cleaning verification. In my experience they are great for detection of all soils... protein, starch, fat, etc. I have used ATP swabs for cleaning verification and to verify a post allergen clean-up for years in the potato industry.

Somewhere in your program you need records to support your Pass/Fail Criteria. Clean a spot and swab it. Clean again. Swab again. Continue this process until the ATP swab reading stops decreasing. Do this with a few locations in your facility. Also do it on different days after different products. The lowest numbers that you can hit consistently will be the pass/fail level. An additional validation would be to follow up the ATP swabs with microbiology tests to confirm that the surface is clean of any harmful bacteria.

ATP swabs are great because they are cheap, real time, and effective.

As for cleaning chemical validation, I think Biss's suggestion is the best. Do a one-time validation that the SSOP will effectively rinse the cleaning chemicals and leave it at that. New validation would only be required if you use new chemical, new equipment or run new products.

[Tony-C]

ATP based swabs are VERY useful for cleaning verification.
Somewhere in your program you need records to support your Pass/Fail Criteria. Clean a spot and swab it. Clean again. Swab again. Continue this process until the ATP swab reading stops decreasing. Do this with a few locations in your facility. Also do it on different days after different products. The lowest numbers that you can hit consistently will be the pass/fail level.
ATP swabs are great because they are cheap, real time, and effective.

Excellent advice. Not sure about cheap but I believe ATP techonolgy should be a norm within the food industry.

[GMO]

Excellent advice. Not sure about cheap but I believe ATP techonolgy should be a norm within the food industry.

Hmm, not 100% in agreement; (sorry for that again Tony) but I've had a situation where (stupidly) a QA said to me "the ATP result passed but I can still see it's dirty" now duh! Reclean it! But if it can pass if it's visibly clean, that just makes me not trust them. Also any swabbing exercise is a small sample, much better to ensure that fully validated procedures (where oodles of traditional swabs were taken to ensure they were ok) are followed and the area is visually inspected IMO. I think ATP gives a false sense of security; as in my example, people sometimes trust science more than their eyes.

[Tony-C]

Hmm, not 100% in agreement; (sorry for that again Tony) but I've had a situation where (stupidly) a QA said to me "the ATP result passed but I can still see it's dirty" now duh! Reclean it! But if it can pass if it's visibly clean, that just makes me not trust them. Also any swabbing exercise is a small sample, much better to ensure that fully validated procedures (where oodles of traditional swabs were taken to ensure they were ok) are followed and the area is visually inspected IMO. I think ATP gives a false sense of security; as in my example, people sometimes trust science more than their eyes.

Yes you've mentioned that before and I commented that my staff have always been instructed not to swab if something looks dirty.

The system isn't perfect but I have seen a marked improvement in product quality as a result of using a positive release system for filling machines using ATP swabs.

[GMO]

I meant "not" visibly clean btw.

Anyway, I think as with anything, it depends upon the management. If your team are the types of people to rely too much on what a machine tells them then ATP is a waste of time. If they always swab the same areas; it's a waste of time. Likewise though if they're the type of people who wouldn't bother checking unless there was a "test", then ATP swabs can be useful. Just far too much reliance on them IMO, even by my company microbiologist! Here's a quote when I started up a factory once

"Swab every food contact belt with an ATP swab after cleaning"
"Ok, but there are 100 belts and about 20 other pieces of food contact equipment, that will cost £180 a week plus the QA's time and delay production for about 2 hours per week costing several £1000s"
"Ok, do 5 per line"
"Erm, so it's that important then????"

Edited by GMO, 19 January 2011 - 07:21 AM.

[nateb]

Good points about the need for equipment to be visually clean FIRST, then verify with ATP swabs. Like so much of a food safety program, each piece of the program works best when it's part of a whole program.

Cleaning verification should include all the senses plus testing instruments. Touch, Feel, Sight, Smell all play a role in inspecting the equipment. Personnel inspecting also should be trained to look and feel under and around machinery too. Stuff that looks good and clean from a standing position can look quite dirty when you get on your knees and look under it.